Data Sheet

Fucithalmic
Fusidic Acid Eye Drops Qualitative and Quantitative Composition Each gram contains fusidic acid anhydrous 10 mg as fusidic acid hemihydrate Ph.Eur. Pharmaceutical Form Sterile viscous eye drops of 1% aqueous sustained release formulation of fusidic acid (microcrystalline suspension) in a carbomer gel. Fucithalmic liquefies and becomes clear on contact with the electrolytes of the tear fluid, and therefore causes less blurring of vision than eye ointment. The viscosity of the carbomer allows easy administration and gives rise to prolonged concentrations of fusidic acid in the tear fluid. Clinical Particulars USES Actions Fucithalmic is an antimicrobial agent that inhibits bacterial protein synthesis. Fucithalmic kills a wide range of gram-positive organisms. It is used to treat bacterial eye infections. Indications Fucithalmic is indicated for the topical treatment of bacterial eye infections where the organism is sensitive to the antibiotic. These may include: bacterial conjunctivitis, blepharitis, sty, and keratitis. Dosage and Administration For all ages: One Fucithalmic drop to be instilled into the eye twice daily. Treatment should be continued for at least 48 hours after the eye returns to normal. Contraindications Hypersensitivity to any of its components. Special Warnings and Precautions for Use Contact lenses should not be worn/used when Fucithalmic is used. The microcrystalline fusidic acid may cause scratches in the contact lens or cornea. Fucithalmic eye drops contain benzalkonium chloride, which is known to discolour soft contact lenses.

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Data Sheet
Fucithalmic eye drops are preserved with benzalkonium chloride. Benzalkonium chloride may cause eye irritation. Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance. Interactions with Other Medicaments and Other Forms of Interaction Not applicable Pregnancy and Lactation Pregnancy There are no clinical data on exposed pregnancies available, but animal studies and many years of clinical experience with systemic and topical fusidic acid suggest that fusidic acid is devoid of teratogenic effect. Consequently any risk to the foetus is unlikely using the very low doses of fusidic acid applied topically in Fucithalmic. Lactation No effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to fusidic acid is negligible. Fucithalmic eye gel can be used during breastfeeding. Effects on Ability to Drive and Use Machines Presumed to be safe or unlikely to produce an effect on the ability to drive or use machinery. Adverse Effects Very common 1/10 Common 1/100 and <1/10 Uncommon 1/1,000 and <1/100 Rare 1/10,000 and <1/1,000 Very rare <1/10,000 Pooled data from clinical studies, including more than 1,500 patients with acute conjunctivitis, showed that undesirable effects occurred in approximately 10% of the patients; primarily short lasting local discomfort in the form of stinging and burning sensation. The most frequently reported adverse drug reactions are various application site reactions such as transient stinging and burning sensation or transient blurring of vision. Urticaria, rash and allergic reactions have been reported. Immune System Disorders: Uncommon: Allergic reaction

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Eye Disorders: Common: Eye burning Eye stinging Uncommon: Eyes tearing Transient blurring of vision Rare: Conjunctivitis aggravated Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus Periorbital oedema Rare: Rash Urticaria Angiooedema General Disorders and Administration Site Reactions: Common: Application site reaction Overdosage Not applicable. Pharmacological properties Pharmacodynamic Properties Fusidic acid exerts its antimicrobial action by inhibition of bacterial protein synthesis. Fucithalmic is active against a wide range of gram-positive organisms, particularly Staphylococcus aureus. Other species against which Fucithalmic has been shown to have in vitro activity include Streptococcus, Neisseria, Haemophilus, Moraxella and Corynebacteria. Psueudomonas and Enterobacteriaceae spp. are not sensitive to fusidic acid. In vivo fusidic acid is not active against Chlamydia trachomatis. Pharmacokinetic Properties The sustained release formulation of Fucithalmic ensures a prolonged contact with the conjunctival sac. Twice daily application provides sufficient fusidic acid concentrations in all relevant tissues of the eye. Fusidic acid penetrates well into the aqueous humour. The biological half-life of Fucithalmic is 7.3 hours and mean antibiotic concentrations after a single dose of one drop 12 hours after administration are 6.0 mcg/mL.

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Pharmaceutical Particulars List of Excipients Benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide and water for injections. Pharmaceutical Precautions Incompatibilities None known. Shelf Life 3 years. Special Precautions for Storage Store below 30C. Keep the tube tightly closed. The tube should be discarded one month after opening. Presentation Package Quantities 5g tube with tamper-evident cap Instructions for Use/Handling None Medicine Classification Prescription Medicine FURTHER INFORMATION Not Applicable Name and Address Under Licence from: LEO Pharmaceutical Products Ltd. A/S Industriparken 55 Ballerup Denmark

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Distributed in New Zealand by: CSL Biotherapies (NZ) Ltd 666 Great South Road Penrose Auckland 1544 New Zealand Telephone number: 0800 502 757 Date of Preparation 30 June 2011 Fucithalmic is a registered trademark of LEO Pharmaceutical Products Ltd. A/S

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